Public assured: FDA to evaluate Russian vaccine first
This handout picture taken on August 6, 2020 and provided by the Russian Direct Investment Fund shows the vaccine against the coronavirus disease, developed by the Gamaleya Research Institute of Epidemiology and Microbiology.
Handout/Russian Direct Investment Fund/AFP
Public assured: FDA to evaluate Russian vaccine first
Gaea Katreena Cabico ( - August 12, 2020 - 2:13pm

MANILA, Philippines — The coronavirus vaccine developed by a Russian research institute will be assessed once it reaches the Philippines, government officials assured the public on Wednesday amid mounting skepticism about its safety and effectiveness.

Russian President Vladimir Putin announced Tuesday that Moscow has developed the first vaccine against the coronavirus dubbed “Sputnik V,” raising concerns about the speed of development of the vaccine.  

“Once an application for clinical trial or registration of the Russian vaccine is filed at the [Food and Drug Administration], we will evaluate it accordingly, FDA Director General Eric Domingo told in a text message.

Russia claimed the vaccine developed by Gamaleya Research Institute of Epidemiology and Microbiology works even though it has not undergone Phase 3 clinical trials—an essential testing phase before receiving regulatory approval. The Philippines may be included in the Phase 3 clinical trials of the vaccine, according to a Washington Post report.

Domingo said the FDA will only approve the use of vaccines if they have been used in widespread testing or Phase 3.

The vaccine, however, is listed as only being in Phase 1 in the latest draft landscape of COVID-19 vaccines published by the World Health Organization.

Health Undersecretary Maria Rosario Vergeire also said the Russian-made vaccine will undergo regulatory process once it reaches the country.

“We can ensure the public na atin itong padaanin sa procedures natin here even though dumaan na ‘yan sa regulatory procedure sa Russia,” she said in a media forum.

(We can assure the public that it will go through our procedures even though it underwent regulatory procedure in Russia.)

Vergeire added the government will study the vaccine’s dossier or case history to check if it went through the necessary processes for vaccine development.

Meeting with Russian vaccine manufacturer

Vergeire also said that the Department of Science and Technology, which leads the government’s coronavirus vaccine panel, will meet with Gamaleya Institute on Wednesday to discuss the Russia-made vaccine.

“Uumpisahan ngayong araw ang pakikipag-usap para makita natin kung ano mang meron ang bakunang ito upang mapag-aralan at makapag-bigay ng rekomendasyon sa ating presidente,” she said.

(We will start the talk today so we can see what does this vaccine have to study it and give recommendations to the president.)

According to the WHO, a total of 168 candidate vaccines against the coronavirus are being developed worldwide. Of the figure, only six have reached Phase 3 of clinical trials.

These include those being developed by University of Oxford/AstraZeneca, China’s Sinovac, Wuhan Institute of Biological Products/Sinopharm, Beijing Institute of Biological Products/Sinopharm, Moderna/NIAID and Bio N Tech/Fosun Pharma/Pfizer.

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